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African countries seem to back a World Trade Organization proposal that would permanently incorporate into international trade law a waiver that has been in place since 2003 to help poor countries import cheaper medicines, but which for various reasons has never been used.

The proposal was discussed at a 5 December meeting where delegates said it was basically agreed but countries such as Mexico, Chile, Peru, Brazil and India with large time differences to Geneva had asked for some more time to consult with their capitals. Brazil confirmed Monday evening that it was waiting for instructions from Brasilia to accept the package.

The council of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is scheduled to meet on 6 December, after which a General Council meeting could adopt a possible decision.

The proposed draft is a “victory for the entire WTO membership,” a developing country official said in an interview, adding that the African countries should feel proud that they had initiated this amendment.

The delegate said the conditions for the waiver, although not used, would improve once it was implemented into the TRIPS agreement. First, laws have to be implemented at the international level before they can be at the national levels, and a waiver was temporary and “anything can happen to it,” the delegate said, adding, but “now it is there.”

Second, so far the waiver has not been tested and with many African countries not even having intellectual property systems, there is a need to go into these countries and make sure they understood the agreement, the delegate said.

The delegate also noted that the proposal has a “strong level of balance” in terms of commercial interests of the patent owners and the need of people for cheap medicines.

But a least developed country (LDC) official disagreed, saying that the fact that the waiver had not really worked in practice had not been addressed in the negotiations and that making it permanent was in the interest of those opposing the waiver.

The delegate also argued that the United States had gotten most of what it had originally wanted in the negotiations. The delegate said that Zimbabwe and Botswana had also indicated that they wanted to make statements indicating reservations for the proposal. These delegates were not reachable before press time.

In 2003, Kenya was the only African country disagreeing with the chairman’s statement, arguing that the waiver was unworkable, but it had to “bite the bullet” and accept the agreement, a Geneva source said.

Last year, Kenya tried to issue compulsory licenses under the TRIPS waiver for the production of HIV/AIDS medicines, but this was stopped by two pharmaceutical companies with headquarters in Europe holding the respective patents that offered voluntary licenses instead in order to avoid negative publicity, the source said. However, the prices of anti-retrovirals came down after the waiver, the source said.

Departure from African Proposal

The draft waiver consists of a TRIPS Article 31 “bis,” an annex and an appendix to the annex. The “bis” part would modify Article 31(f) which states that production under compulsory license should be predominantly for domestic use. A 30 August 2003 waiver allowed for export to countries with inadequate production facilities but this would have to be made permanent at a later stage (IPW, WTO/TRIPS, 5 December).

While the “bis” part will cover issues such as remuneration, the annex will cover terms for notification of use and how to avoid parallel trade. The appendix to the annex is what used to be the annex of the 2003 decision and covers assessments of countries’ production facilities.

In addition, the chairman of the TRIPS Council, Choi Hyuck of Korea, has proposed a “choreography” for a re-reading of a statement read aloud by the General Council chairman on 30 August 2003. In this statement, 11 countries partially opted out of the waiver, vowing they would use it only in cases of national emergencies. Sources from this group confirmed that all of these countries support the choreography idea, which is intended to ensure the legal significance of the chairman’s statement is neither elevated nor lessened from before.

A developing country official called the main text “operative,” as it was the agreement with real exceptions to Article 31(f), and the annex “procedural,” as it only refer to implementation, and welcomed this division.

But this proposal is different from that tabled earlier this year by the African Group, which aimed to remove cumbersome procedural requirements through technical changes. The 2003 decision, however, did not provide a mandate for changing the decision, but only for making the waiver permanent, two developing country sources said.

One of the sources said that Africa would have liked to get more in the negotiation, but that given the circumstances this was a good deal. The delegate said that a number of countries had supported the African proposal as “a good basis” for further work but they should have gone further as the African Group could not have done it alone.

The LDC source attributed the change of heart of the African group from its original proposal to “political pressure.”

The developing country delegate also said that the deal was a matter of “not losing what you already have.” Another developing country official said that the waiver would become a part of the TRIPS agreement and this was a window of opportunity now. After becoming permanent, the use of it, or lack thereof, could be questioned, for example in annual reviews, the delegate said. The LDC delegate, however, questioned whether such reviews would change anything.

But one of the developing country officials was still positive on behalf of the African countries, saying that “what we have proved [is that] we can make things happen in this house [WTO].”

The developing country sources also emphasised that it was the nature of negotiations that one could not get exactly what one wanted, and they argued that both the United States and the African group had had to compromise.

Another developing country official said that the proposal was different from both the African as well as the US proposal. The US never tabled a proposal but originally wanted the chairman’s statement to be incorporated into the amendment in a written form.

Another source familiar with the current proposal described it as more or less cut and paste from the 2003 decision.